Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Stroke

In brief

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Key facts

Study ID

NCT02313909

Run by

Bayer

People needed

7213

Starts

2014-12-23

Expected to finish

2018-02-15

Last updated by the study team

2019-01-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recent ESUS (between 7 days and 6 months), defined as:
• Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
• Absence of cervical carotid atherosclerotic stenosis> 50% or occlusion, and
• No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and
• No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
• No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)

You may not qualify if…

• Severely disabling stroke (modified Rankin score ≥4)
• Indication for chronic anticoagulation or antiplatelet therapy
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m\^2

Where it is running

• Study site — Long Beach, California, United States
• Study site — Stanford, California, United States
• Study site — Torrance, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Gainesville, Florida, United States
• Study site — Joliet, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Lexington, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Mount Clemens, Michigan, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Erie, Pennsylvania, United States
• Study site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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